Comparing two methods for treating strictures in Crohn's disease

Randomized Trial of Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

This study is testing whether a new method called endoscopic stricturotomy works better than the standard endoscopic balloon dilatation for treating small bowel blockages in people with Crohn's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05009212 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of endoscopic stricturotomy versus endoscopic balloon dilatation in patients with Crohn's disease who have symptomatic small bowel strictures. The study focuses on patients diagnosed with Crohn's disease for at least three months and experiencing multiple fibrotic strictures. By comparing these two endoscopic techniques, the trial seeks to determine which method is more effective in alleviating obstruction caused by strictures. The findings could provide valuable insights into optimal treatment strategies for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Crohn's disease who have multiple small bowel strictures and are currently in remission.

Not a fit: Patients with strictures longer than 5 cm or those not in remission may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with Crohn's disease and small bowel strictures, potentially reducing the need for surgical interventions.

How similar studies have performed: While endoscopic balloon dilatation is well-established, the approach of endoscopic stricturotomy is relatively novel and has not been extensively tested in prospective studies.

Eligibility criteria

Inclusion Criteria:

1. Subjects had been diagnosed with CD for at least 3 months prior to screening, and the diagnosis of CD had clinical findings and endoscopic, imaging evidence, and was supported by histopathology reports
2. Subject is in remission from CD (CDAI score \< 150)
3. Subjects had clinical findings of multiple fibrotic strictures of the bowel with obstruction and imaging evidence, and/or endoscopic evidence
4. Subjects had ≤ 3 small bowel strictures (length \< 5 cm) from duodenum to rectum and \< 50 cm distance between strictures
5. Study process prior to initiation, the subject or subject's legal representative (if applicable) signed and dated a written informed consent form or any required documentation of privacy authorization
6. Female subjects who remained sexually and of childbearing potential with an ungerminated male partner, consented to adequate routine contraception throughout the study period starting with signing informed consent

Exclusion Criteria:

1. At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
2. Subjects were in active CD (CDAI score ≥ 150)
3. The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
4. Presence of ileostomy, colostomy
5. Subjects had a history or evidence of adenomatous colonic polyps that had not been resected or had a history or evidence of dysplasia of the colonic mucosa, including low - or high-grade dysplasia, and an undiagnosed type of dysplasia
6. Subjects had suspected or confirmed ulcerative colitis, undiagnosed types of colitis, ischemic colitis, radiation enteritis, colitis associated diverticular disease, or microscopic colitis
7. Subjects had evidence of active infection during the screening period
8. Subject has active tuberculosis
9. Subjects with any defined inborn or acquired immunodeficiency (e.g., common various immunodeficiencies, human immunodeficiency virus \[HIV\] infection, organ transplantation)
10. Subjects had a clinically significant infection (e.g., pneumonia, pyelonephritis) or an ongoing chronic infection within 30 days prior to screening
11. The subject suffered from any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immune, endocrine / metabolic or other medical condition that, in the opinion of the investigator, would interfere with the outcome of the study or jeopardize the safety of the subject
12. The subject's medical history included malignancy
13. Subjects had abnormal laboratory results for any of the following during screening: hemoglobin \< 5 g / dl; white blood cell (WBC) count \< 3 ×10E9 / L; platelet count \< 100 × 10E9 / L or \> 1200 × 10E9 / L; alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 × upper limit of normal (ULN), and serum creatinine \> 2 × ULN.
14. Subjects were unable to attend all study visits or comply with study flow plans female subjects were pregnant prior to study enrollment, during study enrollment, or plan to donate eggs during these time periods
15. Subjects were forced to consent to participate in the study
16. Investigators considered the subject unsuitable for endoscopic treatment

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qin Guo, MD — The Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Qin Guo, MD

Conditions Crohn Disease; Stricture; Bowel; Endoscopy, Gastrointestinal